Cleared Traditional

K932603 - APOLIPOPROTIEN B (APO B) (FDA 510(k) Clearance)

Class I Chemistry device.

K932603 · Sigma Diagnostics, Inc. · Chemistry device
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Jun 1994
Decision
370d
Days
Class 1
Risk

K932603 is an FDA 510(k) clearance for the APOLIPOPROTIEN B (APO B). Classified as Turbidimetric Method, Lipoproteins (product code JHN), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 2, 1994 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K932603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1993
Decision Date June 02, 1994
Days to Decision 370 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
282d slower than avg
Panel avg: 88d · This submission: 370d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHN Turbidimetric Method, Lipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.